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BIO Submits Comments Viral Shedding Draft Guidance

<p>
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the &ldquo;Draft Guidance for Industry on Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products.&rdquo; BIO greatly appreciates the Agency&rsquo;s work to develop this guidance and notes our support expressed previously in comments on the Draft Guidance for Industry on Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products.</p>

BIO recommends that FDA and the Sponsor discuss any potential shedding studies early in the development of a drug product, even though FDA will not request studies during Phase 1. BIO notes that it is of utmost importance that the data generated from shedding studies be based on sound scientific principles to ensure confidence in the risk mitigation and communication strategies that are derived from them.  The comments then discuss the use of terms and definitions throughout the Draft Guidance, the utility of preclinical shedding studies, and further guidance to particular aspects of clinical shedding studies.  The comments go on to provide FDA with specific line item edits to enhance the Draft Guidance’s clarity and utility.